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o IRB Metrics
 Review the appropriate metrics (for example, time from submission to first review) to evaluate the quality, efficiency, and effectiveness of the IRB review process;
13.3.3 Other EQuIP Quality Improvement Activities
o Metrics of EQuIP Activities
o Assist with AAHRPP Accreditation Process
o Conduct surveys to evaluate effectiveness of various aspects of the McLaren’s HRPP
o Identify, review, analyze, report, and disseminate new and pertinent regulations and guidelines
o Identify needed improvements to HRPP policies, procedures, and guidelines
13.3.4 Corporate Director of HRPP and Compliance Reviews
All internal quality assurance and audit reports, both research-related and HRPP- related, will be reviewed by the Director of HRPP and the Institutional Official (when necessary) in order to determine if systemic changes are required in the HRPP to prevent re-occurrence. If so, a corrective action plan will be developed, implemented and evaluated by the Director of HRPP and IO (when necessary).
Annually, the Corporate Director of HRPP will define at least one targeted measure of operational efficiency and effectiveness and at least one targeted measure of compliance within the HRPP. In order to evaluate whether the targeted measures are being achieved, the Corporate Director of HRPP (or delegate) collects and records data every 6-month. At the end of each year, the Corporate Director of HRPP evaluates whether the respective goals were achieved, and adjusts the affected processes to correct any deficiencies.
 Reporting and Disposition
The results of all internal quality assurance activities and audit reports
are reported to the Corporate Director of HRPP.
If an audit or review finds that subjects in a research project have been exposed to unexpected serious harm, the reviewer will promptly report such findings to the Director and the IRB Chair for immediate action.
Human Research Protections Program Manual McLaren Health Care
Revised 12/1/16
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